Entry Level Pharmacovigilance Associate
Company: Lambda Therapeutic Research Ltd.
Location: Ahmedabad, Gujarat, India
Department: Pharmacovigilance – Global Delivery Center
Job Type: Full-Time
Work Mode: Office-Based
Shift: EU Shift (1:00 PM – 10:00 PM)
JOB OVERVIEW
The Entry Level Pharmacovigilance Associate is responsible for supporting global drug safety operations by processing adverse event reports, managing Individual Case Safety Reports (ICSRs), maintaining pharmacovigilance databases, and ensuring compliance with global regulatory requirements and Good Pharmacovigilance Practices (GVP). This role provides hands-on exposure to global safety operations through structured training and professional development while contributing to accurate, timely, and high-quality safety reporting.
KEY RESPONSIBILITIES
ICSR Case Processing
Receive, review, and process Individual Case Safety Reports (ICSRs).
Validate safety cases according to regulatory requirements.
Perform case data entry into pharmacovigilance databases.
Ensure timely completion of assigned safety cases.
Maintain case quality and accuracy throughout processing.
Adverse Event Management
Collect and evaluate adverse event reports.
Support adverse drug reaction (ADR) reporting activities.
Review source documents for reportable safety information.
Identify missing information and initiate follow-up when required.
Maintain accurate documentation of adverse events.
Safety Database Management
Enter and update safety information in global safety databases.
Maintain accurate and complete pharmacovigilance records.
Ensure data consistency and integrity.
Perform quality checks on entered data.
Support database maintenance activities.
Regulatory Compliance
Follow Good Pharmacovigilance Practices (GVP).
Comply with global pharmacovigilance regulations and SOPs.
Maintain confidentiality of safety information.
Support inspection-ready documentation.
Adhere to regulatory reporting timelines.
Quality Assurance
Perform self-quality checks on processed cases.
Maintain high standards of data accuracy.
Identify and correct data discrepancies.
Follow established quality procedures.
Support continuous quality improvement initiatives.
Training & Professional Development
Participate in structured pharmacovigilance training programs.
Develop knowledge of global drug safety regulations.
Learn pharmacovigilance systems and workflows.
Build expertise in safety reporting processes.
Contribute to continuous learning initiatives.
EDUCATIONAL QUALIFICATIONS
Required
Bachelor of Pharmacy (B.Pharm)
Master of Pharmacy (M.Pharm)
Doctor of Pharmacy (Pharm.D)
Bachelor of Dental Surgery (BDS)
Master of Dental Surgery (MDS)
EXPERIENCE REQUIREMENTS
Required
Freshers and early-career professionals are encouraged to apply.
Preferred
Basic understanding of Pharmacovigilance and Drug Safety
Strong written and verbal communication skills
Willingness to learn and work in a global environment
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Remote, India | Siliguri |Illinois :
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Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Massachusetts :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Geelong Vic | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | Whitesboro | Winston-Salem |Georgia :
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Birmingham |Virginia :
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Concord | Lumberton | North Carolina |Michigan :
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Dickinson |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Frank Scottile Blvd |Missouri :
Fulton | Milan | St. Louis |United States :
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Germany | GErmany |Lower Saxony :
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Hamburg |Rhineland Palatinate :
Ingelheim am Rhein | Mainz |Schleswig Holstein :
Kiel |Berlin :
Mitte |Mecklenburg Vorpommern :
Rostock |Saarland :
Saarbrucken |Switzerland :
Basel | Zurich |Serbia :
Belgrade | Serbia |Hungary :
Budapest |BULGARIA :
Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Istanbul :
Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
Romania |Belgium :
Wavre |Tipperary :
Ballydine |Cork :
Brinny | Ringaskiddy |Carlow :
Carlow |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
Dunboyne |Dún Laoghaire :
Dún Laoghaire |Galway :
Galway |County Dublin :
Swords |Republic of China :
Beijing |China :
China | Quarry Bay |Liaoning :
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Shanghai Shi |Hubei :
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Leiden |Netherlands :
Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Witney |Ontario :
Mississauga | North York | Renfrew | Richmond Hill | Australia | Uxbridge |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Argentina | Peru |Brazil :
Sao paulo | Brazil |Attica :
Koropi | Athens |Greece :
Greece |North Island :
Auckland |New Zealand :
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Austria |Vienna :
Vienna |Catalonia :
Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
Hà Nội | Hanoi |Ho Chi Minh :
Ho Chi Minh City |Italy :
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Surabaya |Japan :
Saitama | Japan |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
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Remote Korea |Republic of Korea :
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New Mexico | Ciudad de México |Dubai :
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Kyiv |Lima Region :
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Paris | Lyon |South Africa :
Midrand | South Africa |Nišava District :
Niš |Bohemia :
Prague |Chile :
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